FDA.reportPublic FDA data

ImmunoCard STAT! FLU A&B

Primary DI
00840733101656
Brand
ImmunoCard STAT! FLU A&B
Company
MERIDIAN BIOSCIENCE, INC.
Model
782030
Catalog number
782030
Device description
ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.Moderate Complexity when used with Nasal Wash/Aspirate Samples. CLIA Waived when used with Nasal and Nasopharyngeal Swabs.
Published
2018-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PSZDevices Detecting Influenza A, B, And C Virus Antigens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSZDevices Detecting Influenza A, B, And C Virus AntigensMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083746000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083746000BIOSIGN FLU A+BPrinceton BioMeditech Corp.2010-11-10PSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101656008407331016568407331016560840733101656

GMDN Terms#

Term, Definition table
TermDefinition
Influenza A/B virus antigen IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of antigens from influenza A virus and/or influenza B virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(513) 271-3700info@meridianbioscience.com

Regulatory Flags#

DUNS number
092815364
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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00840733102318Revogene6102106102102020-07-15
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00840733103285Revogene Check6102206102202022-06-27
00840733103339Para-Pak C&S9006-019006122021-06-18
00840733102011Para-Pak C&S9006129006122020-12-09
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00840733102455Para-Pak Ultra SAF9802129802122020-12-09
00840733102851Para-Pak Ultra SAF9802129802122020-12-09
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